Long-term follow-up data from the BIOSOLVE-IV registry, presented at the EuroPCR 2021 meeting (18–20 May, virtual), strengthens the clinical evidence for Biotronik’s Magmaris resorbable magnesium scaffold (RMS) as a therapy option for patients with coronary artery disease, the company said. Jan Torzewski, head physician at the Cardiovascular Center Oberallgaeu-Kempten, Kempten, Germany, presented the two-year results for the first cohort at the virtual EuroPCR meeting.
BIOSOLVE-IV investigates the clinical performance and long-term safety of the Magmaris RMS in a real-world setting. In the first cohort of 1,075 patients, from more than 100 clinical sites in total, the target lesion failure2 (TLF) rate was 6.6% at 24 months. The outcomes demonstrated a very good safety profile, no increase in scaffold thrombosis between 12-month and 24-month follow-ups and a cardiac death rate of 0.5%, Biotronik said in its press release.
“Our results confirm the low TLF rate of the Magmaris scaffold that we have seen in other long-term studies, such as BIOSOLVE-II and -III,” said Torzewski, one of the registry’s principal investigators.
Pooled results from the BIOSOLVE-II and BIOSOLVE-III trials (n=174) recently demonstrated TLF rates of 6.3% at 36 months and the BIOSOLVE-II trial alone demonstrated a TLF rate of 8% at 60 months for the Magmaris RMS. No definite or probable scaffold thrombosis was observed in these studies.
“Furthermore, this bioresorbable scaffold is safe and comparable to various second-generation drug-eluting stents on the market,” commented Torzewski.
Indeed, bioresorbable scaffolds aim to provide comparable performance to existing metallic drug-eluting stents, while delivering complete scaffold resorption within a certain time period to facilitate complete vessel healing. The Magnesium backbone dissolves in the body approximately 95% at one year after implantation.
“The data shows that Biotronik’s Magmaris RMS is an innovative, bioresorbable scaffold that can provide a true therapy option for coronary artery disease,” commented Alexander Uhl, president vascular intervention at Biotronik. “We are excited to examine the benefits that our next generation magnesium scaffold, DREAMS 3G, will provide for both patients and physicians, patient enrolment for the BIOMAG-I first-in-man study is ongoing.”